Clinical effectiveness of a patient decision aid to improve decision quality and glycaemic control in people with diabetes making treatment choices: a cluster randomised controlled trial (PANDAs) in general practice

Abstract

ObjectiveTo determine the effectiveness of a patient decision aid (PDA) to improve decision quality and glycaemic control in people with diabetes making treatment choices using a cluster randomised controlled trial (RCT).DesignA cluster RCT.Setting49 general practices in UK randomised into intervention (n=25) and control (n=24).ParticipantsGeneral practices Inclusion criteria: >4 medical partners; list size >7000; and a diabetes register with >1% of practice population. 191 practices assessed for eligibility, and 49 practices randomised and completed the study. Patients People with type 2 diabetes mellitus (T2DM) taking at least two oral glucose-lowering drugs with maximum tolerated dose with a glycosolated haemoglobin (HbA1c) greater than 7.4% (IFCC HbA1c >57 mmol/mol) or advised in the preceeding 6 months to add or consider changing to insulin therapy. Exclusion criteria: currently using insulin therapy; difficulty reading or understanding English; difficulty in understanding the purpose of the study; visual or cognitive impairment or mentally ill. A total of 182 assessed for eligibility, 175 randomised to 95 intervention and 80 controls, and 167 completion and analysis.InterventionBrief training of clinicians and use of PDA with patients in single consultation.Primary outcomesDecision quality (Decisional Conflict Scores, knowledge, realistic expectations and autonomy) and glycaemic control (glycosolated haemoglobin, HbA1c).Secondary outcomesKnowledge and realistic expectations of the risks and benefits of insulin therapy and diabetic complications.ResultsIntervention group: lower total Decisional Conflict Scores (17.4 vs 25.2, p<0.001); better knowledge (51.6% vs 28.8%, p<0.001); realistic expectations (risk of ‘hypo’, ‘weight gain’, ‘complications’; 81.0% vs 5.2%, 70.5% vs 5.3%, 26.3% vs 5.0% respectively, p<0.001); and were more autonomous in decision-making (64.1% vs 42.9%, p=0.012). No significant difference in the glycaemic control between the two groups.ConclusionsUse of the PANDAs decision aid reduces decisional conflict, improves knowledge, promotes realistic expectations and autonomy in people with diabetes making treatment choices in general practice.ISRCTN Trials Register Number14842077.

Development and evaluation of a patient decision aid for young people and parents considering fixed orthodontic appliances

“…The reduction in decisional conflict after completion of the FADA was expected and supports the hypothesis that people who use a decision aid are more likely to make an informed and value-based decision, and as a result, they are more likely to persist with their decision (de Achaval et al, 2012) and may have better outcomes (Mathers et al, 2012). However, others have argued that the decisional conflict can encourage appropriate deliberation and enhance doctor-patient relationship (O'Connor, 1995b, O'Connor, 1995a, Nelson et al, 2007a, Nelson et al, 2007b).…”

Toma de decisiones compartidas en la atención de pacientes con diabetes mellitus: un desafío para Latinoamérica

“…Luego de realizar una búsqueda sistemática de la literatura, encontramos seis ECA que evaluaron HATD en pacientes con diabetes mellitus [22][23][24][25][26][27] (Tabla 1). En general, estos estudios confirmaron los resultados de la revisión Cochrane.…”

Managing diabetes in people with dementia: a realist review

“…The participants also felt more engaged in their diabetes management despite the lack of clinical outcomes. Similarly, Mathers et al, 111 in a RCT of a decision aid for patients with type 2 diabetes (adults aged between 42 and 87 years), found no statistical effect on glycaemic control (HbA 1c decreased in both intervention and control groups), but decision-making by patients was more autonomous and promoted more realistic expectations and greater knowledge. The authors suggested that this can lead to better long-term SM practices.…”

“…Both of these studies involved the use of a decision aid in a single consultation between a clinician and a person with diabetes. In the Mathers et al 111 study, the mean duration of the consultation was 15.31 minutes. People living with dementia and diabetes are likely to need interventions that involve more frequent contact and include repetition and reinforcement.…”